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FDA 510(k)

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

K-Number: K041926 · 2004-11-23

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2004-11-23
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K041926. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278?

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K041926.

When did HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 receive FDA 510(k) clearance?

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 received FDA 510(k) clearance on 2004-11-23, under 510(k) number K041926.

Who is the listed applicant for HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278?

The FDA product code for HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 is JIX.

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Related Devices (Code: JIX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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